Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation - Tabular View

Tracking Information

First Received Date ^ICMJE

April 9, 2002

Last Updated Date

February 6, 2009

Start Date ^ICMJE

March 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Complete response [ Designated as safety issue: No ]
Partial response [ Designated as safety issue: No ]
Stable disease [ Designated as safety issue: No ]
Progressive disease [ Designated as safety issue: No ]
Time to complete remission [ Designated as safety issue: No ]
Survival at 2 years [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Complete response
Partial response
Stable disease
Progressive disease
Time to complete remission
Survival at 2 years

Change History

Complete list of historical versions of study NCT00033475 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation

Official Title ^ICMJE

Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients

Brief Summary

RATIONALE: Some types of lymphoproliferative disease are associated with Epstein-Barr virus. Combining reduced immunosuppressive therapy with donor white blood cells that have been treated in the laboratory to kill cells infected with Epstein-Barr virus may be an effective treatment for lymphoproliferative disease.

PURPOSE: Randomized phase III trial to compare the effectiveness of reducing immunosuppressive therapy with or without donor white blood cells in treating patients who have Epstein-Barr virus-associated lymphoproliferative disease after organ transplantation.

Detailed Description

OBJECTIVES:

Determine the efficacy of treatment with partially HLA-matched allogeneic cytotoxic T cells and reduction of immunosuppression, in terms of survival rate and time to remission in patients with Epstein-Barr virus-associated B-cell lymphoproliferative disease after solid organ transplantation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to transplanted organ type and transplant center. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo sliding-scale reduction of immunosuppressive drugs from 1 of 5 regimens at physician's discretion. Patients then receive partially HLA-matched allogeneic cytotoxic T cells IV over 5 minutes once weekly for a total of 4 weeks.
Arm II: Patients undergo reduction of immunosuppression as in arm I alone. Patients are followed monthly for 6 months and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Active Control

Condition ^ICMJE

Lymphoproliferative Disorder

Intervention ^ICMJE

Biological: therapeutic allogeneic lymphocytes

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of post-transplant lymphoproliferative disease (PTLD) after solid organ (heart, heart/lung, liver, liver/gut, pancreas, or kidney) transplantation
- Epstein-Barr virus-positive tumor
- Newly diagnosed disease
Measurable disease by clinical methods or radiography
Must have partially matched donor cytotoxic T cells (CTL) available
No known panel reactivity to any of the HLA types of CTL available for therapy

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

Karnofsky 20-100%

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

No prior therapy for PTLD
No concurrent antiviral drugs (e.g., acyclovir or ganciclovir) for PTLD

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00033475

Responsible Party

Study ID Numbers ^ICMJE

CDR0000069288, CRUK-EBV-CTL, LCMV-CTL, EU-20057

Study Sponsor ^ICMJE

University of Edinburgh

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Dorothy H. Crawford, MD

University of Edinburgh

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP